Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

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Brief Title

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Official Title

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Brief Summary

      The objective of this study is to explore the effects of Sirolimus on the underlying
      molecular alterations of cerebral aneurysms.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in gene expression from control arteries.


Condition

Cerebral Aneurysm

Intervention

Microsurgical clipping

Study Arms / Comparison Groups

 Microsurgical Clipping Treated with Sirolimus
Description:  Participants undergoing standard of care microsurgical clipping of unruptured cerebral aneurysm will be treated with 2 mg Sirolimus daily for 14-18 consecutive days prior to surgery.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

80

Start Date

December 1, 2020

Completion Date

December 1, 2025

Primary Completion Date

December 1, 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Undergoing one of the following procedures at Jackson Memorial Hospital:

               -  Clipping of an unruptured cerebral artery aneurysm

               -  Endovascular treatment of unruptured cerebral aneurysms (including those
                  receiving coiling)

          2. ≥ 18 years of age

          3. Willing and able to give informed consent

        Exclusion Criteria:

        1) Subjects meeting any of the following criteria will be excluded:

          -  Dissecting, traumatic, or mycotic brain aneurysm.

          -  Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.

          -  Women who are breastfeeding.

          -  Any clinically significant psychiatric or psychological disease, which would preclude
             the patient from completing the protocol.

          -  Patients with known Human Immunodeficiency Virus (HIV) infection or other known
             immunodeficiency.

          -  Patient with renal or liver failure

          -  Interstitial pneumonitis

          -  History of lymphoma

          -  History of skin cancer

          -  Hypersensitivity to sirolimus

          -  Severe or unstable concomitant condition disease or chronic condition, which in the
             opinion of the investigator could affect assessment of the safety or efficacy of study
             intervention.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert M Starke, M.D., 305-243-3806, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04141020

Organization ID

20190857

Secondary IDs

1R01NS111119-01A1

Responsible Party

Principal Investigator

Study Sponsor

University of Miami

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Robert M Starke, M.D., Principal Investigator, University of Miami


Verification Date

September 2020